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The Computer Systems Validation (CSV) Manager for both Enterprise Quality Systems and QC Lab will be responsible to lead, guide, and support cross-functional teams in the adoption and application of risk-based Computer Systems Validation/Computer Software Assurance practices to enable an interconnected/interoperable and GxP compliant digital ecosystem at AbCellera. This role is hands-on, highly cross-functional, and will work closely with IT to support the implementation and operation of multiple IT systems including those supporting R&D, Manufacturing, Quality Control and Quality Systems.

We’d love to hear from you if:

• You are a passionate leader and critical thinker with the ability to motivate, inspire, and contribute to highly effective teams

• You are comfortable operating in an evolving, complex, and dynamic environment, and driving against the deliverables of a digital roadmap

• You are an independent contributor to the design, development, and implementation of the CSV/CSA program, to include developing and/or supporting procedures, guidance, and best practices

How you might spend your days:

• Leading, coaching/mentoring, training, and developing cross-functional teams responsible for innovative, risk-based validation of Enterprise and QC impacting computerized systems

• Overseeing and participating in validation planning and/or the execution of qualification and validation activities for new software system implementations

• Creating and improving computer system validation related policies, procedures, guidance, templates, forms, etc.

• Leading and guiding GxP applicability and system assessments tailored for the computerized system’s intended use

• Authoring, reviewing and approving qualification and validation documentation (URS/specifications, testing and qualification protocols (IQOQPQ)/UAT), risk assessments, reports)

• Leading and supporting data governance and data integrity compliance for computerized systems including FDA 21 CFR Part 11 - Electronic Records; Electronic Signatures, EU-PIC/S-Health Canada Annex 11 - Computerised Systems, EMA - Guideline on computerised systems and electronic data in clinical trials, and other evolving GxP Data Integrity requirements and guidance

• Working closely with vendors and system integrators to review and providing feedback on vendor deliverables (validation plans, risk assessments, qualification protocols, etc.), including making decisions to accept and leverage vendor documentation as part of validation strategies

• Working closely with business functions and IT to provide expertise in CSV/CSA strategies, manage identified issues, and support continuous improvement

• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations in a true Quality by Design environment

• Reviewing and approving computer system related change controls, discrepancies, deviations and CAPAs

• Supporting inspection readiness programs and/or directly supporting regulatory agency inspections. Assisting in the coordination/content of responses to any findings as applicable

Required qualifications and experience:

• Bachelor's degree in Information Systems, Engineering or similar technical discipline required

• Minimum 8+ years of experience working in the Biotech/Pharmaceutical industry or related Life-Science industries in Quality Compliance or Computerized System Validation / Computer Software Assurance roles

• Strong knowledge of Good Automated Manufacturing Practices (GAMP) principles and Computer Software Assurance for Production and Quality System

• Strong knowledge in 21 CFR Part 11, Annex 11, and applicable data integrity requirements, standards, and guidelines

• Strong background and understanding of Health Canada, EU, and FDA regulations

• Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP)

• Experience in authoring/reviewing/approving validation documentation

• Working knowledge of the software development lifecycle (SDLC)

• Experience supporting enterprise software deployments and laboratory/manufacturing equipment and instruments (such as LIMS, QMS, DMS, LMS)

• Excellent written and verbal communication skills with ability to work with cross-functional teams

• Experience with vendor audits, system level agreements and quality agreements

• Ability to manage multiple, complex projects